Postmenopausal OsteoporosisPhase 3NCT05060406
A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
A Phase 3 study testing LY06006 in people with Postmenopausal Osteoporosis, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- LY06006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2019to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal woman, ages ≥50 to ≤85 years.≥3 years postmenopausal, which can be≥3 years of spontaneous amenorrhea or ≥3 years post-surgical bilateral oophorectomy. If < 60 years of age and had hysterectomy but ovarian retention, require follicle stimulating hormone (FSH) levels ≥40U/L.
Who cannot join
- Low BMD (BMD absolute value consistent with a T-score≤-2.5 and >-4.0 at either the lumbar spine or total hip). The BMD equivalents by T-score thresholds for each DXA scanner manufacturer are provided below.
- Have at least one of the following risk factors:
- history of fragility fracture
- parental history of hip fracture
- low body weight (BMI≤19kg/m2)
- elderly (age≥65y)
Show all 49Show fewer
- current smoker
- Voluntarily signed written informed consent
- Bone/metabolic disease:
- Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
- Paget's disease
- Cushing's disease
- Hyperprolactinemia
- Hypopituitarism
- Acromegaly
- Current hyperparathyroidism or hypoparathyroidism by medical record.
- Current hyperthyroidism or hypothyroidism (allowed if having normal hormone level on thyroid hormone replacement therapy or 5.5μIU/mL<thyroid-stimulating hormone (TSH) level≤10.0μIU/mL, but the serum thyroxine (T4) is within the normal range.
- Malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example Crohn's Disease and chronic pancreatitis.
- Hypocalcemia or hypercalcemia, or serum albumin corrected blood calcium level is not within the normal range of the laboratory;
- Vitamin D deficiency: 25 hydroxy vitamin D (25OHD) level <20 ng/mL. (allowed 200,000 units of vitamin D2 injection (trade name: Futai®) once during the screening period, and re-test the 25OHD level once. Those with 25OHD level ≥20 ng/mL can be included
- Others such as rheumatoid arthritis, gout, multiple myeloma and so on.
- Subjects with a history of greater than 2 vertebral fractures.
- Malignancy within the 5 years before enrollment (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ).
- Severe renal disease, creatinine clearance <30mL/min
- Liver or biliary diseases:
- Cirrhosis of the liver;
- Biliary tract abnormalities (except asymptomatic gallstones);
- Positive Hepatitis C virus (HCV) antibody;
- Positive hepatitis B surface antigen (HBsAg) test with the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥1×103 copies/mL (if positive HBsAg with the peripheral blood HBV DNA titer test <1× 103 copies/mL, the subject is eligible for selection if the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject,;
- Alkaline phosphatase <lower limit of normal (LLN); alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal (ULN); serum aspartate aminotransferase (AST) ≥ 2.0×ULN; serum alanine Acid aminotransferase (ALT) ≥2.0×ULN;
- Oral/Dental Diseases
- Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- Active dental or jaw condition which requires oral surgery.
- Planned invasive dental procedure.
- Non-healed dental or oral surgery.
- DXA measurements:
- Less than two lumbar vertebrae evaluable for DXA measurements.
- Height, weight, or girth that could preclude accurate DXA measurements.
- Administration of the following medications:
- RANKL inhibitor, fluoride or strontium salt or intravenous bisphosphonate within the past 5 years;
- Oral bisphosphonates, allowed if patients had the following conditions :
- Cumulative use> 3 months but <3 years: ≥ 6 months before the last medication was taken from the screening visit;
- Cumulative use ≤3 months;
- parathyroid hormone (PTH) or parathyroid hormone analogs (PTHa) within 6 weeks before screening, such as teriparatide; anabolic hormones or testosterone; glucocorticoids (equivalent to> 5 mg/day strength Pine> 10 days); systemic hormone replacement therapy; selective estrogen receptor modulators (SERMs), such as raloxifene; tibolone; calcitonin; active vitamin D and its analogs; other bone active drugs including anticonvulsants (except benzodiazepines) and heparin; long-term systemic use of ketoconazole, androgens, corticotropin, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, Gonadotropin releasing hormone agonist;
- Positive human immunodeficiency virus (HIV) antibody.
- Self-reported alcohol or drug abuse [defined as drinking an average of 14 units or more of alcoholic beverages per week in the 3 months before screening (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine)]
- Known allergy to the treatment drugs used in the research protocol, including allergy to the test drugs
- Have received any other experimental drug treatment or prior participation in another interventional clinical trial within 3 months before screening
- Other severe acute or chronic diseases, psychiatric disorder or abnormal laboratory tests, etc., in the opinion of the investigator, not suitable for participating in this research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Zhenlin Zhang, doctor, 13621673716, zzl2002@medmail.com.cn
Zhenlin Zhang, doctor
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.
Read the detailed description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.
Primary Objective:
To evaluate the efficacy of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Secondary Objectives:
To evaluate the safety of LY06006. To evaluate the immunogenicity of LY06006. Population pharmacokinetic analysis of LY06006.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- LY06006
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY06006Drug
Also called recombinant human monoclonal anti-RANKL antibody injection
60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
| Study group | Role | What they receive |
|---|---|---|
| LY06006 60mg | Experimental | injection
Interventions:
Drug: LY06006 Injection； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D Receives: Drug: LY06006 |
| Placebo | Placebo comparator | injection
Interventions:
Drug: Placebo； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D Receives: Drug: LY06006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12
Measured: Baseline and Month 12
Secondary outcomes (6)
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Percent Change From Baseline in BMD at the Lumbar Spine at Month 6
Measured: Baseline and Month 6
Percent Changes in total hip BMD
Percent Changes in total hip BMD from baseline at 6 and 12 months of treatment
Measured: Baseline,Month 6 and Month 12
Percent Changes in femoral neck BMD
Percent Changes in femoral neck BMD from baseline at 6 and 12 months of treatment
Measured: Baseline,Month 6 and Month 12
Percent Changes in trochanteric BMD
Percent Changes in trochanteric BMD from baseline at 6 and 12 months of treatment
Measured: Baseline,Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1, Month 6, and Month 12
Measured: Baseline, Month 1, Month 6 and Month 12
Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline
Percent Change From Baseline in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline at Month 1, Month 6, and Month 12
Measured: Baseline, Month 1, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start30 Jun 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Zhenlin Zhang, doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060406
- Sponsor's protocol ID
- LY06006/CT-CHN-302
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
- ClinicalTrials.gov ID
- NCT05060406
- Acronym / sponsor ID
- LY06006/CT-CHN-302
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.
Detailed description
It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.
Primary Objective:
To evaluate the efficacy of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Secondary Objectives:
To evaluate the safety of LY06006. To evaluate the immunogenicity of LY06006. Population pharmacokinetic analysis of LY06006.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- It is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
| Arm | Type | Receives |
|---|---|---|
| LY06006 60mg | Experimental | Drug: LY06006injection Interventions: Drug: LY06006 Injection； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Drug: LY06006injection Interventions: Drug: Placebo； Dietary Supplement: Elemental Calcium； Dietary Supplement: Vitamin D |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal woman, ages ≥50 to ≤85 years.≥3 years postmenopausal, which can be≥3 years of spontaneous amenorrhea or ≥3 years post-surgical bilateral oophorectomy. If < 60 years of age and had hysterectomy but ovarian retention, require follicle stimulating hormone (FSH) levels ≥40U/L.
Key exclusion criteria (49 listed)
- Low BMD (BMD absolute value consistent with a T-score≤-2.5 and >-4.0 at either the lumbar spine or total hip). The BMD equivalents by T-score thresholds for each DXA scanner manufacturer are provided below.
- Have at least one of the following risk factors:
- Voluntarily signed written informed consent
- Bone/metabolic disease:
- Subjects with a history of greater than 2 vertebral fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY06006Also: recombinant human monoclonal anti-RANKL antibody injection60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total | Drug | LY06006 60mg, Placebo |
Primary outcome
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Time frame: Baseline and Month 12
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12
6 secondary outcomes
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine
Time frame: Baseline and Month 6
Percent Changes in total hip BMD
Time frame: Baseline,Month 6 and Month 12
Percent Changes in femoral neck BMD
Time frame: Baseline,Month 6 and Month 12
Percent Changes in trochanteric BMD
Time frame: Baseline,Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline
Time frame: Baseline, Month 1, Month 6 and Month 12
Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline
Time frame: Baseline, Month 1, Month 6 and Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenlin Zhang, doctor principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY06006 in people with Postmenopausal Osteoporosis, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenlin Zhang, doctor (13621673716, zzl2002@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.